Brumipril 2,5mg capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ramipril

Available from:

Brupharmexport SPRL

INN (International Name):

ramipril

Dosage:

2,5mg

Pharmaceutical form:

capsules

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUMIPRIL 2.5 MG - 5 MG - 10 MG CAPSULES
Ramipril
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
- If any of the side effects become serious, or if you notice any side
effect not listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What BRUMIPRIL is and what it is used for
2. Before taking BRUMIPRIL
3. How to take BRUMIPRIL
4. Possible side effects
5. How to store BRUMIPRIL
6. Further information
1. WHAT BRUMIPRIL IS AND WHAT IT IS USED FOR
BRUMIPRIL contains an active substance known as ramipril. Ramipril
belongs to a group of medicines
called "ACE Inhibitors" (angiotensin-converting enzyme inhibitors).
BRUMIPRIL acts by:
. Promoting the reduction of production by your body of substances
which increase your blood pressure
. Promoting the relaxation and enlargement of your blood vessels
. Making it easier for your heart to pump blood to the entire body
BRUMIPRIL can be used for:
. Treating high blood pressure (hypertension)
. Reducing the risk of heart attack or stroke
. Reducing the risk or delaying the aggravation of kidney problems
(whether you are diabetic or not)
. Treating the heart when it is unable to pump sufficient blood to the
rest of your body (heart failure)
. Treatment following a heart attack (myocardial infarction) when
complicated by heart failure
2. BEFORE TAKING BRUMIPRIL
DO NOT TAKE BRUMIPRIL
- If you are allergic (hypersensitive) to ramipril, other ACE
inhibitory medicines or any other ingredients of
BRUMIPRIL (see section 6)
The signs of allergic reactions can include rash, difficulty in
swallowing or breathing, swelling of your lips,
face, throat or tongue.
- If you have ever had a severe allergic reaction called "angio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BRUMIPRIL 2.5 mg
BRUMIPRIL 5 mg
BRUMIPRIL 10 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BRUMIPRIL 2.5 mg
Each capsule contains 2.5 mg of ramipril.
BRUMIPRIL 5 mg
Each capsule contains 5 mg of ramipril.
BRUMIPRIL 10 mg
Each capsule contains 10 mg of ramipril.
Complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule.
BRUMIPRIL 2.5 mg, Capsule: size 4 capsule, pale grey colour body and
pale green cap, containing a white
or off-white powder.
BRUMIPRIL 5 mg, Capsule: size 4 capsule, pale grey colour body and
green cap, containing a white or off-
white powder.
BRUMIPRIL 10 mg, Capsule: size 4 capsule, pale grey colour body and
dark green cap, containing a white
or off-white powder.
1
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
- Treatment of hypertension.
- Cardiovascular prevention: reduction of cardiovascular morbidity and
mortality in patients with:
- manifest atherothrombotic cardiovascular disease (history of
coronary heart disease or cerebrovascular
accident (stroke) or peripheral vascular disease); or
- diabetes associated to at least one cardiovascular risk factor (see
section 5.1).
- Treatment of renal disease:
- Incipient diabetic glomerular nephropathy as defined by the presence
of microalbuminuria,
- Clinically manifest diabetic glomerular nephropathy as defined by
the presence of macroproteinuria in
patients with at least one cardiovascular risk factor (see section
5.1),
- Clinically manifest non-diabetic glomerular nephropathy, defined by
the presence of macroproteinuria ≥ 3
g/day (see section 5.1).
- Treatment of symptomatic heart failure.
- Secondary prevention following acute myocardial infarction:
reduction of mortality following the acute
phase of the myocardial infarction in patients with clinical signs of
heart failure starting over 48 hours after
an acute myocardial infarction.
4.2 Posology and method of administration
Oral route.
The recommended administration of BRUMIPRIL is a single daily dose,